MAUDE Adverse Event Report: ETHICON INC. SFXSPI PDS+ BI VIO 6IN2 3-0 DA RB-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP2B431
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a prostatectomy procedure on an unknown date and suture was used.During multiple prostatectomy procedures that either the needle would popped off the suture or the suture would break.Another like device was used to continue with the procedure.There were no adverse consequences reported.No product returning.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 3/10/2025 h6 component code: g07002 - device not returned.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.It was reported that ".During multiple prostatectomy procedures that either the needle would popped off the suture or the suture would break." please confirm the number of patients affected by this alleged deficiencies.Have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).If no, please create a new pc file for each patient/event.Please provide information requested below for each patient/event.Please confirm below, on how many devices ".The needle would popped off the suture.") from each product code? product sxpp1b420 (lot 1018q2): product sxpp2b431 (lot tlbjee): what was being done when the needle pulled off (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? did the needle fall into the patient? if so, please provide the following information: were x-rays taken to locate the needle? please confirm below, on how many devices ".The suture would break." from each product code? the needle would popped off the suture product sxpp1b420 (lot 1018q2): product sxpp2b431 (lot tlbjee): when did the suture breakage happened (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

• Brand Name: SFXSPI PDS+ BI VIO 6IN2 3-0 DA RB-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21560350
• Report Number: 2210968-2025-02502
• Device Sequence Number: 21232877
• Product Code: NEW
• UDI-Device Identifier: 10705031464735
• UDI-Public: (01)10705031464735(17)250930(10)TLBJEE
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K192144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: SXPP2B431
• Device Lot Number: TLBJEE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown